Status:
RECRUITING
Effect of Metformin on Healthy Live Birth in Women With Prediabetes
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Ren Ji Hospital of Shanghai Jiao Tong University
Women's Hospital of Zhejiang University
Conditions:
Metformin
Prediabetes
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
Detailed Description
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes and to determine whether either starting metformin pretreatment before ovaria...
Eligibility Criteria
Inclusion
- Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
- Women aged 20-40 years.
- Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.
Exclusion
- Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasma glucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol/L.
- Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.
- Women with un-corrected hyperthyroidism or hypothyroidism.
- Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
- Women with a diagnosis of adenomyosis.
- Women with untreated hydrosalpinx.
- Women who plan to undergo PGT-SR or PGT-M.
- Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
988 Patients enrolled
Trial Details
Trial ID
NCT06064669
Start Date
February 22 2024
End Date
December 31 2027
Last Update
May 29 2024
Active Locations (1)
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1
Shandong University
Jinan, Shandong, China